Affiliated Health Systems and Performance Sites

Affiliated Health Systems and Performance Sites

Affiliated Health Systems and Performance Sites

Rowan University faculty, staff and students should read the information below when conducting research at affiliated health systems and performance sites below. Conducting research at the sites below may require additional forms to be submitted and reviewed by the Institutional Review Boards (IRB) of those sites or approval, procedures to be followed for the use of data about a living individual for research purposes. Faculty, staff and students can contact the Rowan IRB office related to any questions or consultation related to conducting research at the sites below. 

Virtua Health

Rowan University Virtua Health College of Medicine and Life Sciences represents schools and institutes, dedicated to improving health for all. The college will transform the practice of medicine using an approach that treats the whole person, not a disease. Driven by world-class physicians and researchers on the leading edge of science, the college aspires to become a national leader in health care education, discovery and innovation. The College has 3 schools and various institutes and centers.

IRB Submission Guidelines for Projects Involving Virtua Health or Rowan University

If your project involves patients, data, or employees from any Virtua Health setting, including Rowan-affiliated practices or Virtua staff, you must submit your project to the Virtua IRB.

  • Rowan faculty, staff, or students relying on Virtua IRB approval must also submit a “Rely on External, Non-Rowan IRB” application to the Rowan IRB for review and approval.
  • If Rowan IRB is the IRB of record, a submission to the Virtua IRB is still required for local context review.

For projects that do not involve Virtua Health in any way (i.e., no Virtua patients, employees, or settings), submit your study to either Rowan or Virtua IRB based on your institutional affiliation.

Important: Submissions that do not follow these guidelines may be returned with instructions to submit to the appropriate IRB.

Additional Requirements for Projects Involving PHI or Limited Data Sets

  • HIPAA/PHI Access: Virtua Health may require additional training before granting access to PHI for research. A Data Use Agreement (DUA) is required for studies involving PHI identifiers.

  • Limited Data Sets: Rowan researchers using limited data sets from Virtua must:

    • Describe the method for obtaining the data in their Rowan IRB Cayuse protocol.
    • Contact Virtua Health Research Administration and/or IRB before accessing or storing the data.
    • Coordinate with Virtua to use a secure terminal or work location for handling PHI.

FAQs: Rowan Faculty Investigators Conducting Research at Virtua - Coming soon

For assistance with Rowan-Virtua engagement, contact Katelynn Huff

Cooper University Health Care

Rowan University and CUH have an IRB reliance agreement governing human subjects collaborative research projects when the research project involves both institutions. This agreement reduces administrative burden for Rowan University faculty and staff, as well as ensuring CMSRU students can participate and be engaged in human subjects research projects, whose PI's are employees of CUH.

Any Rowan University faculty and/or staff conducting research in collaboration with CUH employees, access and use of CUH data for research purposes, or conducted at CUH facilities should complete and submit a Cooper Rowan Engagement Assessment form for review by the Rowan and Cooper IRBs. This assessment form is necessary to help and guide faculty and staff research to identify the IRB they should submit to for a review of their research project.

Question: When is a Cooper Rowan Engagement Assessment Form necessary?

Answer: When a Principal Investigator or research/study staff do not hold a dual appointment and the proposed research activities are conducted at both insitutions.

Example 1: Rowan PI faculty, who does not have an appointment with CUH, wants to conduct recruitment and enrollment activities at CUH locations/sites.

Example 2: Rowan PI faculty, who does not have an appointment with CUH, wants to access and use patient medical chart data or enroll CUH patients as research subjects.

Example 3: CUH PI, who does not have an appointment with CMSRU, wants to access and use student educational records and class/course information or enroll CMSRU students as research subjects.

Example 4: CUH PI, who does not have an appointment with CMSRU, wants to conduct research activities at CMSRU sites and locations.

Cooper Rowan Engagement Assessment Form

CMSRU students that participate in human subjects research conducted at CUH facilities or when the Principal Investigator is a CUH employee, that does not have a dual appointment at CMSRU, or involves use of CUH data, may participate in research as a researcher. Such projects, including all participating in research, must be submitted to the CUH IRB. All policies and procedures of CUH and the CUH HRPP/IRB must be followed by all engaged in the above scenario. CMSRU students may not be PI at CUH.

CMSRU students conducting human subjects research where there is no involvement of CUH employees, CUH locations or use of CUH data must find a Rowan/CMSRU faculty to be the Principal Investigator project and submit their propsed study to the Rowan IRB. 

Click here to contact Cooper University Hospital IRB

For assistance with Rowan-Cooper engagement, contact Katelynn Huff

Cooper Medical School of Rowan University (CMSRU) - Office of Medical Education (OME)

When submitting a Cayuse IRB application where educational data and records will be used, please contact Office of Medical Education Administration to discuss the project and data that is available. The contact for the Office is Dr. Susan Perlis.

Use the form below to review data that the Office of Medical Education can provide in relation to a Rowan Cayuse IRB submission. The data to be obtained should also be listed as a separate document and attached in the Rowan Cayuse IRB submission as a data collection sheet.

Available Data from OME - Click here to view data.

 

Jefferson Health New Jersey/Thomas Jefferson University (TJU)

To review detailed guidance and directions related to submitting a Rowan Cayuse IRB submission when the research will include TJU, click on this link: Rowan IRB and Jefferson Health IRB Guidance

Rowan IRB and Jefferson IRB Determination Form